Amgen Inc. v. F. Hoffmann-LaRoche LTD et al
Filing
633
Opposition re #544 MOTION for Summary Judgment of No Inequitable Conduct filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Appendix A#2 Appendix B)(Toms, Keith) Additional attachment(s) added on 7/6/2007 (Paine, Matthew).
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Case 1:05-cv-12237-WGY
Document 633-3
Filed 07/05/2007
Page 1 of 7
Appendix B. Rejections Faced in the `179 that were Not Disclosed in the `178
Date
10/23/87
`178 Line of Prosecution
Application filed
Examiner in the `178 Line
`179 Line of Prosecution
Application filed
Examiner in the `179 Line
Ex. Kushan
Amgen files preliminary amendment adding new claims 65-69, directed to a process for the preparation of an in vivo biologically active polypeptide. (R. Ex. 10 (AM-ITC 0095320708)).
Claim 65: a process for the preparation of an in vivo biologically active glycosylated polypeptide comprising the steps of: (a) growing a mammalian host cell which is capable of effecting posttranslational glycosylation of polypeptides expressed therein and which is transformed or transfected with an isolated DNA sequence encoding a polypeptide having a primary structural conformation sufficiently duplicative of that of naturally occurring human erythropoietin to allow possession of the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells, or the progeny thereof, under nutrient conditions suitable to allow, in sequence, (i) transcription within said host cell of said DNA to mRNA in the sequence of transcription reactions directed by the nucleotide sequence of said DNA;
Ex. Tanenholtz
5/24/88
Dockets.Justia.com
Case 1:05-cv-12237-WGY
Document 633-3
Filed 07/05/2007
Page 2 of 7
Date
`178 Line of Prosecution
Examiner in the `178 Line
`179 Line of Prosecution
(ii) translation within said host cell of said mRNA to a polypeptide in the sequence of translation reactions directed by the nucleotide sequence of said transcribed mRNA; (iii) glycosylation within said host cell of said polypeptide in a pattern directed by the amino acid sequence of said translated polypeptide and sufficiently duplicative of the pattern of glycosylation of naturally occurring human erythropoietin to allow possession by the translated glycosylated polypeptide product of the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells; and (b) isolating the glycosylated polypeptide so produced.
Examiner in the `179 Line
Ex. Kushan 8/3/88
Examiner Tanenholtz rejected claims 65-69 as obvious and unpatentable over Yokota and Gething. Yokota taught and claimed the production of a glycosylated product. Odre argued that the claims were directed to a "novel series of process steps wherein a mammalian host cell capable of glycosylating the expressed polypeptide is first transformed or transfected with a DNA sequence encoding a
Ex. Tanenholtz
Ex. Kushan
Ex. Tanenholtz
9/27/88
Appendix B-2
Case 1:05-cv-12237-WGY
Document 633-3
Filed 07/05/2007
Page 3 of 7
Date
`178 Line of Prosecution
Examiner in the `178 Line
`179 Line of Prosecution
specifically delineated polypeptide, i.e., one having a sufficient amino acid sequence homology to natural human erythropoietin to allow it to qualify ... for potential in vivo biological activity." This shows that Odre viewed the `178 claims as the inherent product of the `179 claims. (R. Ex. 38 (AM-ITC 0095327278)).
Examiner in the `179 Line
12/1/88
Amgen filed an amendment, amending claims 41, 55, and 56 and adding new claims 61-66. Claim 41 was directed to a glycoprotein product having the primary structural conformation and glyc. sufficiently duplicative of naturally occurring EPO.... Amgen did not disclose the August 1988 rejection to Examiner Kushan. (R. Ex. 96 (AM-ITC 0094110518)). Kushan rejected the pending claims of the `178 over concerns that the particular glycosylation of rEPO and uEPO was not sufficiently defined. (R. Ex. 109 (AM-ITC 00941147-60)).
Examiner Kushan
Examiner Tanenholtz
Ex. Kushan
Ex. Tanenholtz
2/10/89
Appendix B-3
Case 1:05-cv-12237-WGY
Document 633-3
Filed 07/05/2007
Page 4 of 7
Date
`178 Line of Prosecution
Amgen cancelled all claims and added new claims 67-75, product-by-process claims, defined as the "glycoprotein product of the expression of an exogenous DNA sequence in a eucaryotic host cell...." Applicant did not inform Examiner Kushan of Tanenholtz's August 1988 rejection, even when making the claims product-by-process. (R. Ex. 86 (AM-ITC 0094116472)). Applicant amended claim 67 to limit the host cell to a "nonhuma n eukaryotic host cell" to avoid a rejection over Sugimoto. Applicant did not inform the Examiner of the prior rejection in the `179. (R. Ex. 97 (AM-ITC 0094118797)). Applicant cancelled claims 6775 and added new claims 76-83 (product-by-process), noting that "[t]hese new claims parallel claim 2 of U.S. Patent No. 4,703,008" confirming that applicant regarded the applications as part of the same overall invention. Furthermore,
Examiner in the `178 Line
Ex. Kushan
`179 Line of Prosecution
Examiner in the `179 Line
Ex. Tanenholtz
6/2/89
Ex. Kushan
Ex. Tanenholtz
7/11/89
Ex. Kushan or Ex. Schain
Ex. Tanenholtz
1/10/90
Appendix B-4
Case 1:05-cv-12237-WGY
Document 633-3
Filed 07/05/2007
Page 5 of 7
Date
`178 Line of Prosecution
Applicant argued that the priority determinations of the different applications rise and fall together (i.e. if Lin was first to invent DNA encoding EPO and the use of that DNA in a host cell, then clearly he was the first to invent the product). Nonetheless, Applicant never disclosed the rejection in the co-pending `179. (R. Ex. 75 (AM-ITC 00941211-20)).
Claim 76: A non-naturally occurring glycoprotein product of the expression in a non-human eukaryotic host cell of an exogenous DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin, said product possessing the in vivo biological property of causing human bone marrow cells to increase production of reticulocytes and red blood cells and having an average carbohydrate composition which differs from that of naturally occurring human erythropoietin.
Examiner in the `178 Line
`179 Line of Prosecution
Examiner in the `179 Line
2/9/90
Schain sent communication to Borun indicating that Applicant's arguments were sufficient to overcome rejections based on §112, but upheld double patenting rejection over Lai. (R. Ex. 249 (AM-ITC 00941224-27)). The `334 interference was
Ex. Schain
Ex. Tanenholtz
Appendix B-5
Case 1:05-cv-12237-WGY
Document 633-3
Filed 07/05/2007
Page 6 of 7
Date
`178 Line of Prosecution
subsequently declared. Fitzgerald issued an Office Action allowing claims 76-83, but Borun opted to continue prosecution via the `874 application. (R. Ex. 4 (AMITC 00941410-15)). `874 application filed Borun filed an IDS listing 394 references, including references of record from both lines of applications. Among the references cited as being of record from the `179 application were Yokota and Gething. However, their significance was not disclosed. (Ex. 25). Applicant filed an amendment, adding new claims 84-94. New claim 86, a product-by-process claim, read "growing...mammalian host cells transformed or transfected with an isolated DNA sequence encoding the human erythropoietin amino acid sequence...." The `179 rejection from August 1988 was never disclosed. (R. Ex.
Examiner in the `178 Line
`179 Line of Prosecution
Examiner in the `179 Line
Ex. Fitzgerald
Ex. Hodges
12/29/93
2/28/94
Ex. Fitzgerald Ex. Fitzgerald
Ex. Hodges Ex. Hodges
4/8/94
Ex. Fitzgerald
Ex. Hodges
6/13/94
Appendix B-6
Case 1:05-cv-12237-WGY
Document 633-3
Filed 07/05/2007
Page 7 of 7
Date
`178 Line of Prosecution
81 (AM-ITC 00941451-54)).
Examiner in the `178 Line
`179 Line of Prosecution
Examiner in the `179 Line
August 1994
Martinell takes over prosecution Martinell rejected claims 87 and 89-97 for indefiniteness and claims 87-94 under §102(b) or §103 based on differences in glycosylation and carbohydrate composition between uEPO and rEPO. Martinell sits for an interview (discusses Sugimoto)
Ex. Martinell Ex. Martinell
Ex. Martinell Ex. Martinell
8/16/94
9/7/94 2/6/95
Ex. Martinell Ex. Martinell
Martinell sits for an interview (discusses Yokota and Gething) Martinell issues notice of allowability
Ex. Martinell Ex. Martinell Ex. Martinell
5/17/95
Martinell issues a Final Office Action, rejecting all pending claims Applicant files `774 continuation application Martinell issues a notice of allowability
Ex. Martinell
6/7/95 3/15/96
Ex. Martinell Ex. Martinell
Ex. Martinell Ex. Martinell
03099/00501 699176.1
Appendix B-7
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